MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-08-28 for FHC MICROELECTRODE manufactured by Fhc, Inc,.
| Report Number | 3002250546-2019-00001 |
| MDR Report Key | 8939498 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-08-28 |
| Date of Report | 2019-08-28 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CRAIG PAGAN |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal | 04287 |
| Manufacturer Phone | 2076665651 |
| Manufacturer G1 | FHC, INC, |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FHC MICROELECTRODE |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2019-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FHC, INC, |
| Manufacturer Address | 1201 MAIN STREET BOWDOIN ME 04287 US 04287 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-28 |